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LATITUDE™ Heart Connect™ System

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LATITUDE™ Heart Connect™ System OPERATOR’S MANUAL LATITUDE™ Heart Connect™ System For online meetings to share data from connected medical equipment Model 3932 Heart Connect™ Application, Model 3300 LATITUDE™ Programming System, Model 3935 iOS Remote Software, Model 3936 Android Remote Software, Model 3937 Desktop Remote Software CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures. Table of Contents INTRODUCTION ...............................................................................1 Trademark Statements......................................................................1 Intended Use ..................................................................................2 Intended Audience ...........................................................................2 Contraindications .............................................................................2 Warnings........................................................................................2 Precautions ....................................................................................3 Adverse Effects ...............................................................................3 How the Heart Connect System Works .................................................3 Security .........................................................................................3 User Roles .....................................................................................4 Components ...................................................................................4 System Limitations and Considerations.................................................5 LOCAL USER: SETTING UP AND UTILIZING THE HEART CONNECT SYSTEM ....................................................................6 Configuring a Connection to the Internet ...............................................6 Heart Connect System Contacts..........................................................7 Starting an Online Meeting.................................................................8 Conducting an Online Meeting ............................................................9 Maintaining Heart Connect Local Software .......................................... 13 REMOTE USER: SETTING UP AND UTILIZING THE HEART CONNECT SYSTEM .................................................................. 13 Creating a User Account.................................................................. 14 Installing Heart Connect Remote Software .......................................... 14 Accepting Contact Invitations............................................................ 14 Receiving Online Meeting Calls......................................................... 15 Joining Online Meetings .................................................................. 15 Participating in Online Meetings ........................................................ 15 Maintaining Heart Connect Remote Software ....................................... 18 INTRODUCTION This manual contains information about setting up and using the Heart Connect™ System. For activation and Heart Connect System access, contact a Boston Scientific representative or Boston Scientific using the information on the back cover of this manual. The following figure provides an overview of the components of the Heart Connect System and how they are connected. [1] LATITUDE™ Programming System, Model 3300 [2] Internet [3] Remote User compatible computing devices (not provided) using Heart Connect Remote Software Figure 1. Components of the Heart Connect System The Heart Connect System consists of the Local User and one or more Remote Users. • The Local User components consist of the Model 3300 Programmer, the Heart Connect software application (Model 3932), and an Internet connection • The Remote User components consist of a compatible computing device (iOS, Android, or Windows operating systems) with the Remote Connect Software installed and an Internet connection. NOTE: Boston Scientific maintains licensing to install the Heart Connect Application (“the Application”) on a BSC Programming System (“Programmer”). Boston Scientific may transfer the license from a Programmer at its sole discretion, as a non-limiting example, in the event of limited or non-use of the Application. NOTE: This manual and the Model 3300 LATITUDE™ Programming System Operator’s Manuals are available online at www.bostonscientific-elabeling. com. Trademark Statements Heart Connect and LATITUDE are trademarks of Boston Scientific Corporation. 1 Trademark statements for third-party trademarks referenced within this manual are listed below: • Internet Explorer and Windows are trademarks of Microsoft Corporation. • iOS is a trademark of Cisco licensed to Apple Inc. • iPhone and iPad are trademarks of Apple Inc. • Android is a trademark of Google Inc. Intended Use The Heart Connect System is an optional data-sharing system intended to display and share physiological and/or other medical data from the Model 3300 Programmer. The Heart Connect System provides health care providers and Boston Scientific personnel with the means to establish an online meeting and share the display of the Model 3300 Programmer with individuals in a remote location. Intended Audience This literature is intended for use by health care providers and Boston Scientific personnel using the Heart Connect System. Contraindications The Heart Connect System is contraindicated for use with medical equipment that is not compatible with system characteristics as defined in this manual. Warnings Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for additional Warnings. WARNING: The use of any cables or accessories with the LATITUDE Programming System other than those provided by or specified by Boston Scientific could result in increased electromagnetic emissions, decreased electromagnetic immunity, or electrical shock of the LATITUDE Programming System. Anyone connecting such cables or accessories to the LATITUDE Programming System, including the use of MSOs (Multiple Socket Outlets), may be configuring a medical system and is responsible to ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems. WARNING: The LATITUDE Programming System is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices1. Under no circumstances should the LATITUDE Programming System be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas. 1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007. 2 Precautions Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for additional Precautions. • Access to patient data. The Model 3300 Programmer transmits display content that may include patient data that are protected health information. Patient data should only be accessed by authorized health care providers and Boston Scientific personnel. For information about protecting patient data and system security refer to "Security" on page 3. Adverse Effects Refer to the LATITUDE Programming System Operator’s Manual, Model 3300 for Adverse Effects. How the Heart Connect System Works The Heart Connect System is utilized by the Local User to establish an online meeting with one or more Remote Users. The Local User uses the Heart Connect application to initiate the meeting and share the Model 3300 Programmer display. Remote Users utilize Heart Connect Remote Software on their own computing device (not provided) to view and communicate with the Local User. The Local User collaborates and/or shares information with Remote Users as needed. An external USB audio device (microphone) must be used by the Local User to enable the meeting audio. Options: • If not using the meeting audio, a telephone may be used by the Local User to communicate with the Remote User(s). • A USB video device (camera) may be used to provide video of the Local User to the Remote User(s). Security The Heart Connect System incorporates security measures for protection of patient data and system integrity. These security measures support general security policies and practices. The online meeting, including any images being transmitted, is encrypted to ensure patient information and device data are protected. Refer to the Patient Data Management Operator’s Manual (Model 3931) for additional patient data security information. Refer to the Network and Connectivity Operator’s Manual (Model 3924) for additional networking and connectivity security information. 3 User Roles IMPORTANT: • The Local User must know how to use the LATITUDE™ Programming System correctly because delays or loss of network communication can occur at any time. If the Local User is too reliant on a Remote User, lost or delayed network communication could result in harm to the patient. • The Local User should meet the expected level of proficiency for use of the LATITUDE™ Programming System for its intended purpose. Refer to the Model 3300 LATITUDE™ Programming System Operator’s Manual for operation and use of the Model 3300 Programmer. • Meeting Participants should have clear expectations about the patient care responsibilities of the Local User versus Remote Users during an online meeting. Situations could arise with respect to patients and the connected medical equipment that require a timely response by the Local User.
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